Study of Plinabulin and Pegfilgrastim in People With Multiple Myeloma Undergoing an Autologous Hematopoietic Stem Cell Transplant (AHCT)

NCT05130827 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 21-337
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

Conditions

Multiple Myeloma

Keywords

Plinabulin; Pegfilgrastim; Autologous Hematopoietic Stem Cell Transplant (AHCT); 21-337

Outcome Measures

Primary Outcomes (1)

• Average duration of absolute neutropenia

  defined as the number of days after treatment in which the absolute neutrophil count is less than 500 x 10\^6/L.

  1 year

Secondary Outcomes (1)

• Incidence of toxicities

  1 year

Study Arms (1)

Plinabulin

EXPERIMENTAL

In this pilot study, 15 patients age 18-75 with multiple myeloma will be admitted to the hospital and treated with a single dose of high dose melphalan. Stem cell infusion will occur per institutional standard of care. Patients will then receive plinabulin 40mg flat dose IV infusion, infused over approximately 30 minutes starting between 1-3 hours after stem cell infusion on day 0. Pegfilgrastim 6mg will be administered as per standard of care on day +1.

Drug: Plinabulin

Interventions

Plinabulin DRUG

40mg flat dose IV infusion, infused over approximately 30 minutes starting between 1-3 hours after stem cell infusion on day 0.

Plinabulin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmation of multiple myeloma by the enrolling institution in patient undergoing autologous HCT with melphalan 140 or 200 mg/m\^2
• Age 18-75
• Have at least 3 x 10\^6 CD34+ autologous stem cells/kg to be infused
• Karnofsky performance greater than or equal to 60 within 2 weeks prior to enrollment.
• Organ function testing within 28 days before enrollment:
• LVEF ≥45% by MUGA or rest ECHO
• Diffusion capacity \>45% (adjusted for hemoglobin) as predicted by pulmonary function testing
• Clinical laboratory values meeting the following criteria within 14 days before enrollment:
• Platelet count ≥ 20 x 109/L
• ALT and AST ≤ 2.5 x ULN
• Total bilirubin ≤ 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
• Calculated creatinine clearance \> 40 mL/min
• All women of childbearing potential must:
• Have a negative serum pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) within 14 days prior to enrollment (and pre-AHCT per institutional guidelines)
• For 180 days after receiving plinabulin practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject)

You may not qualify if:

• Other malignancy within the past 2 years, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
• Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity. Patients with Hep B Core Antibody positivity can be enrolled if the Hep B PCR is negative, and they are on antiviral suppression.
• Patients with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate treatment at the time of enrollment.
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment
• Had hospitalization for infection or major surgery (e.g., requiring general anesthesia) within 14 days before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate
• A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 180 days after plinabulin
• Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the PI; or unwillingness or inability to follow the procedures required in the protocol.
• Significant cardiovascular history:
• History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before study drug administration
• Uncontrolled arrhythmia
• History of congenital QT prolongation
• Electrocardiogram (ECG) findings consistent with active ischemic heart disease
• New York Heart Association Class III or IV cardiac disease;
• Uncontrolled hypertension: blood pressure consistently \>150 mm Hg systolic and \> 100 mm Hg diastolic in spite of antihypertensive medication
• Prior transient ischemic attack or cerebrovascular accident with in the past year (within an 18-day window). Any neurologic toxicities ≥ Grade 2 within 3 weeks of randomization.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• BeyondSpring Pharmaceuticals Inc.: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

NPI 2358

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gunjan Shah, MD, MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot trial investigating a single dose of plinabulin on day of stem cell infusion (Day 0) in conjunction with pegfilgrastim on Day +1 after autologous hematopoietic cell transplant (AHCT).

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: November 23, 2021
• Study Start: December 21, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (7)